Applicator for Dispensing a Medical Substance and Methods Associated Therewith

ABSTRACT

An applicator 270 includes a stem 174 having an axially-formed slot delivery passage 200. A slot 350 is formed transaxially through the stem 174 and is in communication with the slot delivery passage 200. An extended side wall 350b is formed on one side of the slot 350. A flat surface 354, which is formed in the stem 174, is spaced and extends angularly away from an opposite side of the slot 176 and from the extended side wall 350b to provide for direct and lateral dispensing of a cream 280 onto a tissue 242 of a patient.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of U.S. Ser. No.14/756,523, filed on Sep. 14, 2015, the entire disclosure of which ishereby incorporated by reference. Application number 14/756,523 is acontinuation application of U.S. Ser. No. 13/573,394, filed on Sep. 13,2012.

BACKGROUND OF THE INVENTION

This invention relates to an applicator for dispensing a medicinalsubstance, and to methods associated therewith. This inventionparticularly relates to an applicator for readily dispensing a medicinalsubstance such as, for example, medicinal cream, compound, or the like,from the applicator, and to methods of dispensing a medicinal substance.

Frequently, various medical conditions exist within affected areas ofopenings of the human body, such as, for example, (1) natural openingsof the anatomy of the human body including, but not limited to, thevaginal opening and the anal opening, and (2) non-natural openings suchas surgically-formed openings, and/or openings resulting from injury.All of the above-noted openings are hereinafter referred to as “bodyopenings.” These medical conditions can be treated with medicinal creamsand other substances of similar consistency. Frequently, such creams areprescribed by physicians, and are to be applied to tissue within thebody openings over a period of time.

Because of the necessity for frequent applications of the cream to theaffected areas, it is beneficial and economical for the patient toself-administer the medicinal cream. However, the cream may be appliedby caregivers other than the patient.

In the past, techniques and devices have been developed to facilitatethe dispensing of the cream generally within the body openings, but havetended not to be formed with structure which dispenses an ample amountof the cream onto the affected areas for a most effective treatment.

Thus, there is a need for a cream-delivery device, such as an applicatoror a tip (both hereinafter referred to as “the applicator”), whichfacilitates the dispensing of an ample amount of medicinal cream ontotissue of the affected areas to be treated. Also, there is a need for acream-delivery device, such as the applicator, which facilitatesextension of the dispensing of the medicinal cream axially beyond athrough slot of the applicator.

SUMMARY OF THE INVENTION

It is, therefore, an object of this invention to provide an applicatorwhich facilitates the dispensing of an ample amount of a substance ontotissue surfaces to be treated.

Another object of this invention is to provide an applicator whichfacilitates extension of the dispensing of a substance axially beyond athrough slot of the applicator.

With these and other objects in mind, this invention contemplates anapplicator for dispensing a substance therethrough, which includes abody formed (1) about an axis which extends from a proximal end of thebody to an exterior axial surface of a closed distal end of the body,and (2) with a proximal section which extends from the proximal end ofthe body toward the closed distal end of the body, and to a distal endof the proximal section. The proximal section of the body is formed withan axial entry passage extending through the proximal section from theproximal end of the body toward the closed distal end of the body, andto a distal end of the axial entry passage, which is formed with aprescribed diameter at the proximal end of the body.

The body is formed with an axial intermediate passage having a proximalend in communication with the distal end of the axial entry passage,which extends toward the closed distal end of the body, and to a distalend of the axial intermediate passage, with the axial intermediatepassage being formed with a uniform passage diameter which is less thanthe prescribed diameter. The body is formed about the axis thereof witha passage section, having a uniform exterior diameter, which extendsfrom a proximal end thereof toward the closed distal end of the body,and to a distal end of the passage section. The passage section of thebody fully surrounds at least a portion of the axial intermediatepassage to the distal end of the axial intermediate passage. The body isformed about the axis thereof with a slot section, having the uniformexterior diameter, which extends from a proximal end of the slot sectiontoward the closed distal end of the body, and to a distal end of theslot section, with the proximal end thereof being formed integrally withthe distal end of the passage section. A slot delivery passage is formedaxially through the slot section of the body from a proximal end thereoftoward the closed distal end of the body, and to a closed distal end ofthe slot delivery passage, with the proximal end of the slot deliverypassage being in communication with the distal end of the axialintermediate passage.

At least one axially-elongated slot is formed radially through the slotsection of the body in unobstructed communication with the axial slotdelivery passage and an external surface of the body, and extends fromthe proximal end of the slot section toward the distal end of the slotsection, and to a distal end of the at least one axially-elongated slot.The slot delivery passage is formed with the uniform passage diameterinterrupted only by the presence of the at least one axially-elongatedslot, which is formed with an extended side wall extending axially froma proximal end to the distal end of the at least one elongated slot. Theextended side wall is located at one side of the at least one elongatedslot, and extends from an inboard juncture of the extended side wallwith the slot delivery passage to an outboard juncture of the extendedside wall with the external surface of the body. A flat surface isformed in the body adjacent the at least one elongated slot, and has afirst end spaced from the extended side wall. The flat surface extendsfrom the first end thereof angularly away from the extended side wall toa second end of the flat surface at a juncture with the external surfaceof the body, and extends axially along at least a portion of the atleast one elongated slot.

As further contemplated by this invention, an applicator includes a bodyhaving a stem formed with a common external surface. A slot deliverypassage is formed axially through at least a portion of the stem, and aslot is formed through a portion of the stem from the slot deliverypassage to the common external surface to facilitate the flow of asubstance from within the slot delivery passage, through the slot, andto an environment adjacent the common external surface. The slot isformed with an extended side wall which extends axially from a proximalend to the distal end of the slot. The extended side wall is located atone side of the slot, and extends from an inboard juncture of theextended side wall with the slot delivery passage to an outboardjuncture of the extended side wall with the common external surface ofthe stem. A flat surface is formed in the stem adjacent the slot, has afirst end spaced from the extended side wall, and extends from the firstend thereof angularly away from the extended side wall to a second endof the flat surface at a juncture with the common external surface ofthe stem.

This invention further contemplates an applicator which includes a bodyhaving a stem formed with a common external surface. A slot deliverypassage, having a surrounding wall, is formed axially through at least aportion of the stem, and a slot is formed radially through a portion ofthe stem, from a mouth in the wall at a juncture of the wall of the slotdelivery passage and the slot, to the common external surface.

The slot is formed with a single extended side wall which extendsaxially, along one side of the slot, from a proximal end to the distalend of the slot. The single extended side wall is located at one side ofthe slot, and extends generally radially outward from an inboardjuncture of the extended side wall with the mouth of the slot deliverypassage to an outboard juncture of the extended side wall with thecommon external surface of the stem. A flat surface is formed in thestem adjacent the slot, and has a first end at a juncture with themouth, which juncture is spaced from the inboard juncture of theextended side wall with the mouth. The flat surface extends from thefirst end thereof angularly away from the mouth of the and from theextended side wall, the flat surface extending to the its juncture withthe common external surface.

This invention also contemplates an applicator for dispensing amedicinal substance therethrough, including a body formed about an axiswith the body extending from a proximal end of the body to a distal endof the body. A stem forms an axial portion of the body, and is formedwith a common external surface. A slot delivery passage is formedaxially through at least a portion of the stem, with a slot formedthrough a portion of the stem from the slot delivery passage to thecommon external surface to facilitate the flow of the medicinalsubstance from within the slot delivery passage, through the slot, andto an environment adjacent the common external surface. The slot isformed with an extended side wall which extends axially from a proximalend to the distal end of the slot, with the extended side wall locatedat one side of the slot, and extending from an inboard juncture of theextended side wall with the slot delivery passage to an outboardjuncture of the extended side wall with the common external surface ofthe stem. A flat surface is formed in the stem adjacent the slot, andhas a first end spaced from the extended side wall. The flat surfaceextends from the first end thereof angularly away from the extended sidewall to a second end of the flat surface at a juncture with the commonexternal surface of the stem, with the flat surface and the extendedside wall extending axially along at least a portion of the slot.

This invention also contemplates a method of delivering cream through acream passage, which comprises the steps of feeding cream through anentry of a cream passage, through the cream passage, and to an exit ofthe cream passage; precluding any lateral movement in a first directionof a first portion of the cream as the first portion of the cream is fedfrom the entry to the exit of the cream passage; and feeding a secondportion of the cream laterally of the first portion of the cream in asecond direction opposite the first direction as the second portion ofthe cream is fed to the exit of the cream passage.

This invention contemplates a method of delivering cream through a creampassage further comprising the step of forming the exit with a firstopen portion and a second open portion which is contiguous with thefirst open portion.

This invention also contemplates a method of delivering cream through acream passage wherein the entry of the cream passage is formed of aprescribed size and the exit of the cream passage is larger than theprescribed size.

This invention further contemplates a method of delivering cream througha cream passage further comprising the steps of establishing aprescribed distance between the entry and the first portion of the exit,and precluding the feeding, for a distance less than the prescribeddistance, of the second portion of the cream laterally through the creampassage.

This invention contemplates a method of delivering cream through a creampassage further comprising the steps of positioning a firstcream-receiving surface at a first portion of the exit, and positioninga second cream-receiving surface at a second portion of the exit.

This invention also contemplates a method of delivering a cream througha cream passage further comprising the step of directing the secondportion of the cream angularly in a second direction opposite the firstdirection as the cream is moved laterally from the first portion of thecream.

The invention also contemplates a method of delivering a cream through acream passage further comprising the steps of feeding the first portionof the cream directly onto the first cream-receptive surface, andspreading the second portion of the cream onto the secondcream-receptive surface.

BRIEF DESCRIPTION OF THE DRAWINGS

In the accompanying drawings:

FIG. 1 is a partially-sectioned top view showing a focused dosimetrydevice, which is supporting a syringe, where a cartridge of the syringeis nested in a carrier of the device having spaced grooves for receivinga flange of the syringe, and further showing the syringe in assemblywith a first prior applicator having slots of the type described, andillustrated, in U.S. Pat. No. 7,125,394;

FIG. 2 is a side view showing structure of the first prior applicator ofFIG. 1, including two, spaced, parallel, interfacing, extended sidewalls, which define a cream-dispensing slot of the applicator;

FIG. 3 is an enlarged partial sectional view showing a proximal end ofthe first prior applicator in assembly with a distal end of the syringeof FIG. 1;

FIG. 4 is a side view showing the first prior applicator of FIGS. 1 and2 formed with integrally-joined sections;

FIG. 5 is a perspective view showing a second prior applicator formedadditionally with an axially-elongated, circular flange having aserrated or splined edge, and a generally cylindrical body, and furthershowing one of the two interfacing dispensing slots, of the typedescribed, and illustrated, in the above-noted U.S. Pat. No. 7,125,394,formed in a slot section, or stem, of the body;

FIG. 6 is a partially-sectioned, perspective view showing a portion ofthe second prior applicator of FIG. 5 with the slot section of the bodythereof being sectioned to show interior structure of the body and toshow the two spaced, parallel, interfacing, first and second extendedside walls of each the two slots;

FIG. 6a is an enlarged sectional view, taken along line 6 a-6 a of FIG.5, showing the spaced relationship of the two parallel, interfacingfirst and second extended side walls of each of the two slots of thebody of the second prior applicator of FIG. 5, with the flange extractedfrom the sectional view for clarity purposes;

FIG. 6b is a sectional view, taken along line 6 b-6 b of FIG. 5, showinginternal structure of the second prior applicator of FIG. 5 withintegrally-joined sections thereof, and formed with axially-aligned,internal, communicating passages of different diameters;

FIG. 7 is a front view of a first current applicator, as described,illustrated, and claimed in this application, showing a splined-edgeflange near a proximal end of the applicator, and further showing one oftwo axially-elongated, diametrically-opposed slots, with each slotformed with a single extended side wall on one side of the slot, thefirst current applicator further formed with a flat, angular, ormulti-configured surface, (hereinafter the “flat surface”), whichextends angularly laterally away from the single extended side wall, anda transaxis plane parallel to the single extended side wall, and towarda common external surface of the first current applicator, the flatsurface extending axially from a proximal end to a distal end of theslot to facilitate the application of a medicinal cream through the fullaxial length of the slot, over and outwardly from the flat surface, andonto tissue of body openings of a patient, in accordance with certainprinciples of the invention;

FIG. 8 is a side view showing additional features of the first currentapplicator of FIG. 7, in accordance with certain principles of theinvention;

FIG. 9 is a partially-sectioned, perspective view showing a portion ofthe first current applicator of FIG. 7 with a slot section, or stem, ofthe body thereof being sectioned to show that the respective flatsurface of each of the two slots extends angularly, laterally, away fromthe respective single extended side wall, and the transaxis plane, inaccordance with certain principles of the invention;

FIG. 10 is a section view taken along line 10-10 of FIG. 8, with aflange extracted from the sectional view for clarity purposes, tofurther show the angular relationship of the single extended side wallof each of the two slots and the respective flat surface, in accordancewith certain principles of the invention;

FIG. 11 is an enlarged view of the sectioned portion of the slot sectionof FIG. 10 showing different angular arrangements of the flat surfacesof the first current applicator, and further showing an abbreviated sidewall of each slot, in accordance with certain principles of theinvention;

FIG. 12 is a sectional view showing the first current applicator of FIG.11 located within a body opening of a patient, and the manner in whichmedicinal cream is applied to tissue within the body opening, includingarrow-indicated flow-paths of the cream, relative to the abbreviatedside wall and the openings of the two slots and the respective flatsurfaces, in accordance with certain principles of the invention;

FIG. 13 is an enlarged view of the sectioned portion of the slot sectionof FIG. 10 showing a second current applicator, as described,illustrated, and claimed in this application, having different angulararrangements of flat surfaces of a second current applicator without theabbreviated side wall of each slot of FIG. 11, in accordance withcertain principles of the invention;

FIG. 14 is a sectional view showing the second current applicator ofFIG. 13 located within a body opening of a patient, and the manner inwhich medicinal cream is applied to tissue within the body opening,including the arrow-indicated flow-paths of the cream, relative to theopenings of the two slots, without abbreviated side walls, and therespective flat surfaces, in accordance with certain principles of theinvention;

FIG. 15 is a front view of a third current applicator, as described,illustrated, and claimed in this application, with the flat surface ofeach slot extending along an axial portion adjacent the respective slot,from a location intermediate the proximal end and the distal end of theslot, to the distal end of the slot, in accordance with certainprinciples of the invention;

FIG. 16 is a partially-sectioned, perspective view showing a portion ofthe third current applicator of FIG. 15, with a slot section, or stem,of the body thereof being sectioned to show interior structure of thetwo slots in relation to the respective flat surfaces, in accordancewith certain principles of the invention;

FIG. 17 is a sectional view showing a plunger located spatially from aproximal end of a barrel of a cartridge, in accordance with certainprinciples of the invention;

FIG. 18 is a sectional view showing the plunger head of FIG. 17assembled within, and located at the distal end of, the barrel of FIG.17, in accordance with certain principles of the invention;

FIG. 19 is a partial sectional view showing a substance loading device,and alternately a squeeze tube, in assembly with the distal end of thebarrel of FIG. 17 with the plunger head being urged away from the distalend of the barrel by the substance being deposited into the barrel, inaccordance with certain principles of the invention;

FIG. 20 is a partial sectional view showing the dispensing end of theloaded barrel of FIG. 17 being closed by a cap, in accordance withcertain principles of the invention;

FIG. 21 is a sectional view showing a stem having a distal end assembledwith the proximal end of the plunger partially within thesubstance-loaded barrel to form a syringe, which is in assembly with anapplicator having slots along the side thereof, to form asyringe/applicator assembly, in accordance with certain principles ofthe invention;

FIG. 22 is a sectional view showing the substance loading device, suchas the squeeze tube of FIG. 19, having loaded the substance into thebarrel, to urge the plunger into engagement with a stop surface formedby the distal end of a guide located within the proximal end of thebarrel, in accordance with certain principles of the invention; and

FIG. 23 is a sectional view showing a syringe/applicator assembly,including the stop surface of FIG. 22, prepared for dispensing thebarrel-contained substance, in accordance with certain principles of theinvention.

DETAILED DESCRIPTION OF THE INVENTION

As noted above, various medical conditions frequently exist withinaffected tissue areas of openings of the human body, such as, forexample, natural openings of the anatomy of the human body, including,but not limited to, the vaginal opening and the anal opening, andunnatural openings such as, for example, but not limited to,surgically-formed openings, and/or openings resulting from injury. Eachof the above-noted natural and unnatural openings is hereinafterreferred to as “a body opening.”

Also, as noted above, the terms “applicator,” “tip,” and “dispenser,”have been used interchangeably, in the past, to refer to acream-dispensing component, of the type which is the subject of theinvention as described, claimed, and illustrated herein. For purposes ofconsistency in the description below, the term “applicator,” will beused throughout, it being understood that such use also refers to theterms “tip” and “dispenser.”

Further, two prior applicators are shown herein in FIGS. 1 through 6, 6a and 6 b, each of which has a cream-passage slot, the width of which isdefined by spaced, parallel, side walls. Such parallel side walls aredescribed and illustrated in U.S. Pat. No. 7,141,036, which issued onNov. 28, 2006.

Containers, for storing a medicinal substance, to which the applicatorsare attachable, are described below, and are used to facilitate thedispensing of the medicinal substance, such as, for example, a medicinalcream, compound, or the like, (hereinafter referred to as “the cream”),onto affected tissue of body openings of a patient, when the applicatorsare located adjacent the tissue.

The consistency of the cream is such that the cream does not flow easilywithin or out of the containers without a force being applied to thestored mass thereof to move the cream from the containers into therespective applicator.

One example of a supply container for storing the medicinal substance isa rapid-delivery system, such as, for example, a piston-operablesyringe, which can be used in conjunction with, or used without, theabove-noted focused dosimetry device, as described below in more detail.A volume of the cream is deposited into a barrel of the syringe, and theapplicator is attached to a distal or output end of the syringe. Thesyringe is operated in a conventional manner to force the cream fromwithin the barrel, into the applicator, through slots of the applicator,and onto the affected tissue of body openings of the patient, which areadjacent outboard portions of the slots.

The volume of the cream deposited initially into the barrel of thecartridge can represent multiple doses of the cream, wherein severalsingle doses can be administered successively through the applicatorover a period of time. Alternatively, the volume of the cream depositedinitially into the barrel of the cartridge can also represent sufficientcream for administering, through the applicator, a single dose only,rather than multiple doses.

Another example of a supply container for storing the cream is a squeezetube, such as, for example, the type typically used to store toothpaste,and facilitate dispensing the toothpaste by squeezing the tube. The tubeincludes an enclosure formed by a flexible wall with a single outlet,which is sealed by a removable cap during periods when it is desired toretain the cream within the enclosure. When it is desired to urge thecream from within the enclosure of the tube, the cap is removed from thesingle outlet of the tube and the applicator is substituted therefor. Byvirtue of the flexible wall of the tube, the tube can be squeezed,pinched, or the like, to urge the cream from within the enclosure,through the single outlet, into the applicator, and through slotsthereof to administer the cream onto the tissue within the body openingof the patient.

Various embodiments of prior applicators, and current applicators, asdescribed below, are particularly useful for applying and focusing eachadministered dose of the cream to affected tissue areas of vaginaland/or anal openings of the human anatomy, but can be used for applyingand focusing the cream to tissue within any natural and/or non-naturalbody openings of the human body.

As described below, the above-noted “prior” applicators refer toapplicators having features, which have been previously disclosed, suchas, for example, the applicator disclosed in the above-mentioned U.S.Pat. No. 7,141,036. As also described below, the “current” applicatorsrefer to applicators having features currently disclosed, claimed andillustrated in this application.

The below-described embodiments of the applicator include a first axial,or proximal, end, at which the cream enters the applicator, and a secondaxial, or distal, end spaced axially distally from the first axial end.The end of any structural portion, such as, for example, an axiallyextending slot, of each of the various embodiments of the applicator,which is closest to the proximal end of the applicator, will be referredto as the proximal end of such structural portion, and the other end ofsuch structural portion or applicator, which is opposite the proximalend, will be referred to as the distal end. For example, an axiallyextended slot formed radially through a body of the applicator willextend between a proximal end and a distal end thereof of the slot.

As shown in FIG. 6a , a cream 280 is being applied onto selectedsurfaces of a tissue 242 within a body opening 244 of a patient.

Referring to FIG. 1, a first technique for applying the cream 280 (FIGS.6a and 12) to the surfaces of the tissue 242 could include the use of afocused dosimetry device 38, described, claimed, and illustrated in U.S.Pat. No. 8,845,596, which issued on Sep. 30, 2014. The device 38 istypically used in multiple dose applications, but can be used for singledose applications, as well. The device 38 can support, and is used with,a syringe 40, which includes a cartridge 42 having a barrel 44. Thesyringe 40 serves as a rapid-delivery, cream-supply container forstoring the cream 280 therein, or storing any other substance having acream-like consistency.

In the syringe 40, the barrel 44 is formed with a hollow interior barrelpassage 46, having a distal opening 48 at a distal end thereof and aproximal opening 50 at a proximal end thereof. A flange 52 is formedradially outward on the barrel 44 at the proximal end thereof. Thesyringe 40 further includes a plunger 54, which is located within thebarrel passage 46, and a stem 56, which is insertable into the proximalopening 50. This structural arrangement facilitates movement of theplunger 54 within the barrel passage 46 toward the distal opening 48thereof, to dispense the cream 280 externally from within the barrelpassage, at the distal end of the cartridge 42.

The device 38 includes a carrier 58, which supports the cartridge 42 andthe stem 56 during use of the device, and, in conjunction with theflange 52 of the barrel 44, facilitates the dispensing of successivesingle-dose applications, or a single dose only, of the cream 280 fromthe barrel.

As shown in FIGS. 1 and 3, the syringe 40 is formed with asmall-diameter sleeve 60 at the distal end thereof, which is an integralpart of the cartridge 42, is in axial alignment with the barrel 44 atthe distal end thereof, and forms a sleeve passage 62 in communicationwith the barrel passage 46. The exterior of the small-diameter sleeve 60is tapered in the form of a frustum, with the smaller diameter of thefrustum located at the distal end of the sleeve, and the axis of thefrustum being coincidental with the axis of the barrel 44.

A large-diameter sleeve 64 is also an integral part of the cartridge 42,at the distal end thereof, and is in axial alignment with the barrel 44,and in coaxial alignment with, and about, the small-diameter sleeve 60.An internal cylindrical wall of (1) the large-diameter sleeve 64 can beunthreaded, such as shown, for example, in FIG. 3, or (2) a similarlarge-diameter sleeve 64 a can be threaded, such as shown, for example,in FIGS. 17 through 22. The proximal end of the large-diameter sleeve 64is closed (FIG. 3) and not in communication with the barrel passage 46,and serves as a stop surface 49 for limiting distal movement of theplunger 54 within the barrel passage.

The structure of the small-diameter sleeve 60 and the large diametersleeve 64 combine to form a cartridge coupler portion 67 of a couplingassembly 45, which will described, in more detail below.

A more detailed description of the structure and the operation of thedevice 38, in conjunction with the syringe 40, is described in theabove-noted U.S. Pat. No. 8,845,596 which is incorporated herein byreference thereto.

Referring to FIGS. 1 through 4, a first prior applicator 66 has a body68, which, as shown in FIGS. 2, 3, and 4, is formed with an applicatorcoupler portion 69 of the coupling assembly 45, and having an axialentry passage 70 therein. The applicator portion 69 of the first priorapplicator 66 is assembled with the cartridge coupler portion 67 of thecartridge 42 at the distal end of the barrel 44 in the form of thecoupling assembly 45 such as the coupling assembly associated with U.S.Registered Trademark LUER-LOK, which is owned by Becton, Dickinson andCompany, having an office in Franklin Lakes, N.J.

In particular, as shown in FIG. 3, the axial entry passage 70 of thefirst prior applicator 66 is formed with a tapered wall 72 which tapersaxially inward from a proximal end of the passage to a distal endthereof, and which mates with the exterior taper of the sleeve 60 of thecartridge 42 to facilitate one aspect of the attachment of the firstprior applicator with the cartridge. The axial entry passage 70, whichis formed with a prescribed diameter at a proximal end 71 of the body68, extends from the proximal end of the body 68 toward a distal end 73of the body and to a distal end 75 of the axial entry passage. The body68 of the first prior applicator 66 is formed within a first ear 74 anda second ear 76, which extend outward in radially opposite directionsfrom the proximal end of the first prior applicator.

As the first prior applicator 66 is being assembled with the cartridge42, the outboard ends of the ears 74 and 76 are inserted within thelarge-diameter sleeve 64 with axial and/or rotational forces applied tothe first prior applicator to frictionally assemble the applicator withthe syringe 40, by the coupling assembly 45. Rotation of the first priorapplicator 66 frictionally enhances the assembly of the taperedsmall-diameter sleeve 60 with the tapered proximal opening 72 of theaxial entry passage 70. The assembly of the syringe 40 with theapplicator 66 is referred to as a cream delivery assembly 67

It is noted that facilities, other than as described above, can be usedto attach the first prior applicator 66 to the cartridge. Suchattachment facilities could be threaded, unthreaded, tapered, press fit,or the like.

As further shown in FIG. 3, the first prior applicator 66 is also formedwith an inner axial delivery passage 78, which extends axially of thebody 68, with a uniform diameter, between an open proximal end 75 and aclosed distal end 90 of the axial delivery passage. The axial entrypassage 70 is in communication with the axial delivery passage 78, withthe distal end of the axial entry passage and the proximal end of theaxial delivery passage being located at the transaxial juncture of thepassages. In the first prior applicator 66, the uniform diameter of theaxial delivery passage 78 is less than the prescribed diameter of theaxial entry passage 70 at the proximal, or entry, end 71 of the passage70.

The axial entry passage 70 could be formed in a configuration other thanthe tapered wall. The uniform diameter of the axial delivery passage 78is less than the prescribed diameter of the axial entry passage 70 atthe proximal, or entry, end 71 of the axial entry passage.

A pair of diametrically-opposed axially extending, elongated slots 80(FIG. 3) and 81 (FIG. 2) are formed in the body 68. Each of the slots 80and 81 are in communication with, and extend radially through the body68 from, the axial delivery passage 78 and exit at a common externalsurface 82 on opposite sides of the body, adjacent exterior portions ofthe slots. As shown in FIG. 3, the slot 80 is formed with two spaced,axially-extending, interfacing, parallel side walls 84 and 85 (FIG. 3),which extend from a proximal end 88 of the slot to a distal end 91thereof, and define the width of the slot. For brevity, each of the sidewalls 84 and 85 are referred to hereinafter as “an extended side wall.”

In similar fashion, the slot 81 (FIG. 2) is formed with spaced,axially-extending interfacing, parallel side walls (i.e., extended sidewalls), which extend from a proximal end of the slot 81 to a distal endthereof, and define the width of the slot. The axial entry passage 70,the axial delivery passage 78, and the slots 80 and 81 are all incommunication with each other to facilitate the smooth flow of the cream280 from the barrel 44 and through the first prior applicator 66 tolocations externally of the first applicator. It is noted that, whilethe above-described first prior applicator 66 includes the pair of slots80 and 81, the first prior applicator could be formed with a singleslot, or more than two slots.

Referring further to FIG. 3, the first prior applicator 66 is formedwith a tactile-indicating flange 92 near the proximal end 71 thereof.The applicator body 68 is formed with the common external surface 82 ofa uniform external diameter, and extends from the flange 92 nearly tothe distal end 73 of the body, and is interrupted only by the openingsof the slots 80 and 81 formed in the common external surface.

The flange 92 extends radially outward from the common external surface82 of the body 68 to an outer edge surface 94 of the flange. The flange92 is formed with a proximal surface 96 facing in a direction toward theproximal end 71 of the body 68 and a distal surface 98 facing in adirection toward the distal end 73 of the body. The distal surface 98 ofthe flange 92 is formed by a straight portion 100 which extends from theouter edge surface 94 of the flange, radially inward toward the axis ofthe body 68 and toward the distal end 73 of the body, to an inboard edgeof the straight portion spaced radially outward from the externalsurface of the body. The distal surface 98 of the flange 92 is formedwith a concave portion 102 which extends from the inboard edge of thestraight portion 100 toward the distal end 73, and to the commonexternal surface 82, of the body 68. The flange 92, with the concaveportion 102 and the angled flat portion 100, provides a user-friendlytactile indication to the patient that the first prior applicator 66 hasbeen inserted into body openings at the appropriate distance forplacement of the slots 80 adjacent the tissue areas to be treated withthe cream 280.

Referring to FIG. 4, and in an alternative manner of describing thefirst prior applicator 66, which is also shown in FIGS. 1, 2 and 3, thefirst prior applicator includes the unitary body 68, formed by sixintegrally-joined sections, identified as a proximal section 104, aflange section 106, a passage section 108, a slot section 110, a solidsection 112, and a dome section 114.

As noted above, the first prior applicator 66 is designed to facilitatethe dispensing of the cream 280 therethrough, where the cream has aconsistency of the type which does not flow without a force beingapplied thereto.

The body 68 of the first prior applicator 66 is formed about an axis116, which extends from the proximal end 71 of the body to the closeddistal end 73 of the body.

The proximal section 104 of the body 68 is formed with the axial entrypassage 70, which extends from the proximal end 71 of the body towardthe closed distal end 73 of the body, and to a distal end 118 of theaxial entry passage. The axial entry passage 70 is formed with aprescribed diameter, at least at the proximal end 71 of the body 68.

The body 68 is also formed with an axial intermediate passage 120 havinga proximal end 122, which is coincidental with the distal end 118 of theaxial entry passage 70. The axial intermediate passage 120 is formedwith a uniform passage diameter, which is less than the prescribeddiameter, and extends toward the closed distal end 73 of the body 68,and to a distal end 124 of the axial intermediate passage.

The body 68 is formed about the axis 116 thereof with the passagesection 108, which has a uniform exterior diameter. The passage section108 extends from a proximal end 126 thereof toward the closed distal end73 of the body 68, and to a distal end 128 of the passage section, andfully surrounds at least a portion of the axial intermediate passage 120to the proximal end 124 thereof.

The body 68 is formed about the axis 116 thereof within the slot section110, and is formed with the uniform exterior diameter. The slot section110 extends from a proximal end 130 thereof toward the closed distal end73 of the body 68, and to a distal end 132 of the slot section, with theproximal end 130 of the slot section formed integrally with the distalend 128 of the passage section 108.

A slot delivery passage 134 is formed axially through the slot section110 of the body 68 from the proximal end 130 of the slot section towardthe closed distal end 73 of the body, and to a closed distal end 136 ofthe slot delivery passage, with a proximal end 138 of the slot deliverypassage being in communication with the distal end 124 of the axialintermediate passage 120.

The axially-elongated slot 80 (hereinafter “the at least oneaxially-elongated slot 80”) is formed radially through the slot section110 of the body 68 in unobstructed radial communication with the slotdelivery passage 134 and an exterior of the body, and extends from theproximal end 130 of the slot section toward the distal end 132 thereof,and to a distal end 140 of the at least one axially-elongated slot 80.The slot delivery passage 134 is formed with the uniform passagediameter, interrupted only by the presence of the at least oneaxially-elongated slot 80.

The body 68 is formed with the solid section 112, having the uniformexterior diameter, which extends from a closed proximal end 142 of thesolid section toward the closed distal end 73 of the body, and to aclosed distal end 144 of the solid section. The closed proximal end 142of the solid section 112 is formed integrally with the distal end 132 ofthe slot section 110.

The body 68 is formed with the dome section 114 in the form of a soliddome 146, which extends from a closed proximal end 148 of the domesection to the closed distal end 73 of the body, with the closedproximal end being coincidental with the exterior axial surface of thedome. The closed proximal end 148 of the dome section 114 is formedintegrally with the closed distal end 144 of the solid section 112. Thesolid section 112 and the dome section 114 are exclusive of any openingtherethrough.

It is noted that the axial intermediate passage 120 of the passagesection 108, and the slot delivery passage 134 of the slot section 110,are axially aligned and combine to form the axial delivery passage 78 asillustrated in FIG. 3. Further, as described above, and with referenceto FIG. 4, the axially aligned axial intermediate passage 120 and theslot delivery passage 134 are formed with the uniform passage diameter.

As further shown in FIG. 4, the flange 92 is located in the flangesection 106, between the proximal section 104 and the passage section108. The flange 92 is integrally joined with adjacent portions of thebody 68, at opposite axial ends of the flange, and fully radiallysurrounds a portion of the axial intermediate passage 120. Thus, exceptfor the presence of the at least one axially-elongated slot 80,successive portions of the body 68, which are located in the threesections identified as the flange section 106, the passage section 108and the slot section 110, surround the axial delivery passage 78 (FIG.3), which, as noted above, is formed by the axial intermediate passage120 and the slot delivery passage 134 illustrated in FIG. 4.

The exterior structure of the flange 92, as illustrated in FIG. 4, isdescribed above with respect to FIG. 3, and is not further describedherein.

With the structure of the body 68 as described above, there is fullcommunication from an exterior of the body, at the proximal end 71thereof, through the axial entry passage 70, the axial intermediatepassage 120, the slot delivery passage 134, the at least oneaxially-elongated slot 80, and an exterior of the body adjacent the atleast one axially-elongated slot.

Referring to FIGS. 5, 6, 6 a, and 6 b, a second prior applicator 160 hasan integrally-formed, unitary body 162, which extends axially along anaxis, or centerline, 164 between a proximal end 166 and a closed distalend 168 of the body. The body 162 is formed integrally with (1) aproximal coupler 170 which extends axially from the proximal end 166 ofthe body, (2) an axially-elongated circular flange 172, (3) anaxially-elongated stem 174 formed transaxially with twoaxially-elongated diametrically-spaced slots 176 and 178 (FIG. 6), (4)an axially-elongated solid spacer 180, and (5) an axially-elongated dome182 which extends axially to the distal end 168 of the body.

A distal end of the proximal coupler 170 is joined integrally, at ajuncture 184 (FIG. 6b ), with a proximal side of the flange 172, and isformed with a cylindrical exterior surface 186 having a prescribedexternal diameter. The flange 172 is formed with a cylindrical exteriorsurface 188 having an external diameter which is greater than theprescribed external diameter. To facilitate manually-controlled rotationof the second prior applicator 160, the perimeter of the exteriorsurface 188 of the flange 172 is formed with parallel, axially-aligned,spaced serrations, or splines, 190, which enhance manual gripping of theexterior surface of the flange.

The flange 172 is further formed with an external, concave, distalsurface 192, which extends integrally between a distal edge 194 of thecylindrical exterior surface 188 and a juncture 196 of a distal end ofthe concave distal surface and a proximal end of the stem 174. The stem174 and the solid spacer 180 are formed with a common external surface195, having an external diameter, which is less than the prescribedexternal diameter. The stem 174 and the solid spacer 180 are integrallyjoined at a juncture 198 (FIG. 6b ) of a distal end of the stem and aproximal end of the solid spacer. A distal end of the solid spacer 180is integrally joined with a proximal end of the dome 182 at a juncture199 (FIG. 6b ) thereof. Also, the solid spacer 180 and the dome 182 aresolid, and do not have any passages, slots, or the like formedtherethrough.

Referring to FIGS. 6a and 6b , the stem 174 is formed axially with aslot delivery passage 200, having a prescribed internal diameter, whichcommunicates with the axially-elongated slots 176 and 178. The slot 176includes a first extended side wall 176 a and a second extended sidewall 176 b, which are parallel to each other, and which define a space176 c, or confined passage, therebetween, for guiding the cream 280(FIG. 12) therethrough in a direct flow path indicated by arrows 177 and177 a.

Note that due to the confined space between the side walls 176 a and 176b, and due to the presence of the side walls to the cream 280 passingthrough the slot 176, the side walls serve as a barrier to any movementof the cream laterally of the flow path indicated by the arrows 177 and177 a, whereby the cream flows directly through the slot from an entry201 of the slot to an exit 176 s thereof.

As shown in FIG. 6a , a transaxis, or centerline, 202 extends radiallythrough, and from, the axis 164 and defines a transaxis planecoincidental with the transaxis. The extended side walls 176 a and 176 bare generally parallel to, and spaced from, each other, and to thetransaxis plane of the transaxis 202.

A proximal wall 176 d, or floor, is formed at a proximal end portion ofthe slot 176, and extends radially between (1) the entry 201, of whichis coincidental with a wall of the slot delivery passage 200, and (2) adistal straight-line juncture 450 of the proximal wall. A proximaltransition surface 176 e or ramp located at a slot exit 176 s, isdefined by the juncture 450 and a curved juncture 452. Further, theproximal wall 176 d is integrally joined at opposite sides with, andextends between, proximal ends of the spaced, first and second extendedside walls 176 a and 176 b, respectively. The proximal transitionsurface 176 e is formed in the common external surface 195, and slopesoutward, in a proximal direction, from the distal juncture 450 to theproximal juncture 452 of the proximal transition surface with the commonexternal surface.

It is noted that the entry 201 of the slot 176 facilitates movement ofthe cream 280 into the slot 176, while the exit 176 s of the slot 176 isformed at the ramp 176 e to facilitate dispensing of the cream 280 fromthe slot. The well-defined travel path of the cream 280, formed by thespaced, parallel side walls 176 a and 176 b, facilitate the creamtravelling directly from the entry 201 of the slot 176 to the exit 176s, and impinging directly onto the prepositioned surface of the tissue242, as shown in FIG. 6 a.

Further, at the distal end of the slot 176 (FIG. 6b ), the slot includesa distal end wall, or floor, 176 f between the spaced, first and secondextended side walls 176 a and 176 b, respectively, at the distal endsthereof. A distal transition surface 176 g is formed in the commonexternal surface 195 in a manner similar to the forming of the proximaltransition surface 176 e, except that the distal transition surfaceslopes radially outward, in a distal direction, from a proximal juncture454 thereof with the distal wall 176 f to a distal juncture 456 thereofwith the common external surface.

As shown in FIGS. 5 and 6 b, the slot 176 extends, by a distance “L,”axially between the proximal juncture 452 and the distal juncture 456.It is noted that the distal juncture 456 of the distal transitionsurface 176 g is coincidental with the juncture 198 of the stem 174 andthe solid spacer 180.

As shown in FIG. 6a , the first extended side wall 176 a of the slot 176is formed dimensionally with a width “W,” which extends in a firstdirection from an integral junction 340 of the side wall with the slotdelivery passage 200 to an integral junction 342 of the side wall withthe common external surface 195. Also, the second extended side wall 176b of the slot 176 is formed dimensionally with the width “W,” whichextends in a second direction from an integral junction 346 of the sidewall with the slot delivery passage 200 to an integral junction 348 ofthe side wall with the common external surface 195.

In the second prior applicator 160, the direction, in which the firstextended side wall 176 a extends from the slot delivery passage 200, isgenerally parallel with the second direction, in which the secondextended side wall 176 b extends from the slot delivery passage. Withthis structural arrangement, the first and second extended side walls176 a and 176 b, respectively, are generally parallel and spaced apartto define, along the axial length “L” of the slot 176, the direct flowpath of the cream 280 through the slot, as indicated by the arrow 177 tothe exit 176 s of the slot, and onto the prepositioned surface of thetissue 242.

Referring to FIG. 6a , the entry 201 defines a mouth of the slot 176,which extends between the integral juncture 340, representing a firstside of the mouth, and the integral juncture 346, representing a secondside of the mouth spaced from the first side of the mouth.

It is noted that a prescribed volume of the cream passage of the slot176 of the second prior applicator 160 is defined by the space betweenthe extended side walls 176 a and 176 b, and the slot length “L” of theslot. The prescribed volume of the slot 178, of the second priorapplicator 160, is defined in the same manner, with respect to theextended side walls 178 a and 178 b and the slot length “L”.

Referring to FIGS. 5, 6 a, and 6 b, the slot 178 is structuredidentically to the slot 176, as described above. The slot 178 includes afirst extended side wall 178 a and a second extended side wall 178 b,which define a space 178 c, or confined passage, therebetween, forguiding the cream 280 (FIG. 6a ) through an entry 203 of the slot, in adirect flow path through the slot, as indicated by an arrow 179, to anexit 178 s and onto the surface of the propositioned tissue 242.

As shown in FIG. 6a , the extended side walls 178 a and 178 b areparallel to, and spaced from, each other, and to the transaxis plane ofthe transaxis 202, or centerline.

A proximal wall, or floor, 178 d is formed at a proximal end portion ofthe slot 178, and extends radially between (1) the entry 203 of theslot, and (2) a distal straight-line juncture 450 a of the proximal walland a proximal transition surface 178 e. Further, the proximal wall 178d is integrally joined at opposite sides with, and extends between,proximal ends of the spaced, parallel, first and second extended sidewalls 178 a and 178 b, respectively. The proximal transition surface 178e is formed in the common external surface 195, and slopes outward, in aproximal direction, from the distal juncture 450 a to a proximaljuncture 452 a of the proximal transition surface with the commonexternal surface.

Further, at a distal end portion of the slot 178, as shown in FIG. 6b ,the slot includes a distal end wall, or floor, 178 f between the spaced,parallel, first and second extended side walls 178 a and 178 b,respectively. A distal transition surface 178 g is formed in the commonexternal surface 195 in a manner similar to the forming of the distaltransition surface 178 e, except that the distal transition surfaceslopes radially outward, in a distal direction, from a proximal juncture454 a thereof with the distal end wall 176 f to a distal juncture 456 athereof with the common external surface.

As shown in FIG. 6b , the slot 178 extends, by the distance “L,” axiallybetween the proximal juncture 452 a of the proximal transition surface178 e, and the distal juncture 456 a of the distal transition surface178 g. It is noted that the distal juncture 456 a of the distaltransition surface 178 g is coincidental with the juncture 198 of thestem 174 and the solid spacer 180.

As shown in FIG. 6a , the first extended side wall 178 a of the slot 178is formed dimensionally with the width “W,” which extends from anintegral junction 340 a of the side wall with the slot delivery passage200 to an integral junction 342 a of the side wall with the commonexternal surface 195. Also, the second extended side wall 178 b of theslot 178 is formed dimensionally with the width “W,” which extends froman integral junction 346 a of the side wall with the slot deliverypassage 200 to an integral junction 348 a of the side wall with thecommon external surface 195. In the second prior applicator 160, thefirst direction, in which the first extended side wall 178 a extendsfrom the slot delivery passage 200, is generally parallel with thesecond direction, in which the second extended side wall 178 b extendsfrom the slot delivery passage.

In this manner, each of the slots 176 and 178 provide a confined radialpath for the travel of the cream 280 directly from the slot deliverypassage 200, in opposite directions. The cream 280 passes through therespective slots along the length “L” of the slots, and generallyparallel to the transaxis plane which is coincidental with the transaxis202, to the environment (i.e., the surfaces of the tissue 242)surrounding the common external surface 195 of the stem 174. transaxisplane

Referring to FIG. 6b , the unitary body 162 of the second priorapplicator 160 is formed in six integrally-joined sections, namely theproximal section 210, the flange section 212, the passage section 214,the slot section 216, the solid section 218, and the dome section 220.

The proximal coupler 170 is located in the proximal section 210, and theflange 172 is located in the flange section 212. A proximal portion ofthe stem 174 is located in the passage section 214, and the remainder ofthe stem is located in the slot section 216. The solid spacer 180 islocated in the solid section 218, and the dome 182 is located in thedome section 220.

As noted above, the slot delivery passage 200, which is located in theslot section 216, is formed with a prescribed internal diameter. Aproximal portion of an axial entry passage 222 is formed in the proximalcoupler 170, and has a proximal entry opening 224 which is coincidentalwith the proximal end 166 of the body 162. A distal portion of the axialentry passage 222 is formed axially, and terminates, in the flange 172.Internal threads 226 are formed in the axial entry passage 222, whichhas an internal diameter greater than the prescribed internal diameterof the slot delivery passage 200.

An axial intermediate passage 228 is formed partially in the flange 172and partially in the stem 174, and extends distally from a proximal endof the passage, located in the flange, to a distal end of the passage,located in the stem 174. The axial intermediate passage 228 is formedwith an internal diameter, which is significantly less than theprescribed internal diameter of the slot delivery passage 200, and isconsiderably less than the internal diameter of the axial entry passage222. An axial, funnel-shaped, transition passage 230 is axiallyinterposed between the distal end of the axial entry passage 222 and theproximal end of the axial intermediate passage 228.

The axial entry passage 222, the axial transition passage 230, the axialintermediate passage 228, the slot delivery passage 200, and the slots176 and 178 are all in communication, so that the cream 280 entering theproximal entry opening 224, under external force, will eventually exit,through outboard portions of the slots, to the environment externally ofthe body 162.

In the second prior applicator 160, the axial length of the slotdelivery passage 200 (26 mm) is approximately two and one-half times theaxial length of the axial intermediate passage 228 (10.65 mm). Inaddition, the diameter of the slot delivery passage 200 (3.18 mm) isapproximately two and three-fifths times the diameter of the axialintermediate passage (1.22 mm). With the length and diameter of the slotdelivery passage 200 as noted above, a sizable chamber 240 is formed bythe slot delivery passage for the reception of significant amounts ofthe cream 280 within the chamber during use of the second priorapplicator 160, for ultimate application of the cream 280 onto surfacesof the tissue 242 (FIG. 12) of a body opening 244 (FIG. 12) of thepatient.

When the second prior applicator 160 is attached to, and used with, arapid-delivery supply container, such as, for example, thepiston-operable syringe 40 (FIG. 1), the cream 280 exits the syringe ata comparatively high-flow rapid-delivery rate. If the second priorapplicator 160 had been formed with an axial intermediate passage havingthe same prescribed internal diameter as the slot delivery passage 200,the cream 280 would be fed directly into the slot delivery passage atthe above-noted high-flow rate.

In this instance, the cream 280, travelling at the high-flow rate, wouldtend to exit proximal portions of the slots 176 and 178 before thechamber 240 can be substantially filled with the cream. This actionwould result, undesirably, in large amounts of the cream 280 beingdispensed onto the surfaces of tissue 242 of the body opening 244adjacent proximal portions of the slots 176 and 178, and smaller amountsdeposited onto the surfaces of the tissue adjacent distal portions ofthe slots.

This disparity of application of the cream 280 onto the surfaces ofadjacent tissue 242 is alleviated by forming the axial intermediatepassage 228 with the above-noted relatively smaller diameter andrelatively shorter length, which is considerably less than the diameterand length of the slot delivery passage 200.

Although limited amounts of the cream 280 exit through proximal portionsof the slots 176 and 178 before the chamber 240 is filled, theabove-noted parametrical relationships amongst the diameters and lengthsof the axial intermediate passage 228 and the slot delivery passage 200enhance the ability of the second prior applicator 160 to allow thechamber 240 to fill with the cream before significant amounts of thecream exit through the slots 176 and 178. This provides for a relativelyeven distribution of the cream 280 along the axial length “L” of theslots 176 and 178 after the chamber 240 is essentially filled with thecream.

In the second prior applicator 160, the solid spacer 180 and the dome182 are solid as noted above. However, as shown in FIG. 6b , a distalpassage 253 could be formed axially through the solid spacer 180 and thedome 182 from and through a distal end of the slot delivery passage 200to and through the distal end 168.

As shown partially at the bottom of FIG. 6a , when the stem 174 of thesecond prior applicator 160 is inserted into the body opening 244,surfaces of the tissue 242 are located at the radially outboard side ofthe slot 176. A similar condition occurs at the radially outboard sideof the slot 178. If the surfaces of the tissue 242 at the radiallyoutboard sides of the slots 176 and/or 178 are dense, and/or the bodyopening 244 is small compared to the diameter of the stem 174,significant opposition to the outflow of the cream 280 onto the surfacesmay result. This opposition results in an insufficient amount of thecream 280 being applied to surfaces of the tissue 242, which areadjacent the radially outboard sides of the slots 176 and 178.

As shown in FIG. 3, it is important to note that the slot 80 of theprior applicator 66 is well defined by the spaced, parallel,interfacing, extended side walls 84 and 85, which results, in the mannershown in FIG. 6a , in the cream 280 being directed generally radiallythrough the slot in the direction shown, for example, by the arrows 177and 177 a. The interfacing portions of the extended side walls 84 and 85are essentially identical dimensionally and structurally so that thecream 280 passing through the slot 80 is confined to the space betweenthe parallel extended side walls. The slot 81 (FIG. 2), of the priorapplicator 66, is arranged in the same manner as the slot 80, with theextended side walls 178 a and 178 b confining the passage of the cream280 in the generally radial direction of the arrows 179 and 179 a (FIG.6a ).

As shown in FIGS. 6 and 6 a, the slots 176 and 178, of the second priorapplicator 160, are essentially identical structurally, dimensionally,and spatially to the slots 176 and 178 of the first prior applicator 66,thereby to confine the passage of the cream 280 through the slots in thesame manner as described above with respect to the slots of the firstprior applicator 66.

Referring to FIGS. 6 and 6 a, the slot 176 of the prior applicator 160is formed with two extended side walls 176 a and 176 b, which arespaced, parallel, and interfacing, to define the opening of the slot,through which the cream 280 will pass. In this arrangement of the slot176 of the prior applicator 160, the extended side wall 176 a occupies afirst location within the opening of the slot, and the extended sidewall 176 b occupies a second location within the opening of the slot. Inthe same manner, the slot 178 of the prior applicator 160 is formed withtwo extended side walls 178 a and 178 b, which ae spaced, parallel, andinterfacing to define the opening of the slot. The extended side wall178 a occupies a first location within the slot 178, and the extendedside wall 178 b occupies a second location within the slot.

It is noted that the first prior applicator 66 and the second priorapplicator 160 are being described above in, and illustrated in FIGS. 1through 6, 6 a and 6 b of, this application to show the structure ofprior applicators, particularly with respect to the structure of theslots, and adjacent structure, of the prior applicators such asdisclosed, for example, in above-noted U.S. Pat. No. 7,141,036.

Referring now to FIGS. 7 through 16, and as described below, each of afirst current applicator 270 (FIGS. 7, 8, 11 and 12), a second currentapplicator 271 (FIGS. 9, 10, 13, and 14), and a third current applicator272 (FIGS. 15 and 16), include features which are described, claimed,and illustrated in this application, and include structure, and methodsof use, which differ from the that of the above-described first priorapplicator 66, and the second prior applicator 160. The first, second,and third current applicators 270, 271, and 272, respectively, areidentified as “current” applicators to identify the applicators whichare described, claimed, and illustrated in this application, incomparison with the first and second “prior” applicators 66 and 160,respectively.

Some of the structure of the below-described first, second, and thirdcurrent applicators 270, 271, and 272, respectively, is similar tocorresponding structure of the above-described first and second priorapplicators 66 and 160, respectively. Therefore, for consistency, someof the numeric, and the alpha-numeric, indicators for the structuralfeatures of the first and second prior applicators 60 and 160, which arecommon to corresponding structural features of each of the first,second, and third current applicators 270, 271, and 272, respectively,will be used to identify the corresponding structural features of thefirst, second, and third current applicators.

As shown in FIGS. 7, 8, and 15, each of the first, second, and thirdcurrent applicators 270, 271, and 272, respectively, has anintegrally-formed, unitary body 162, which extends along an axis, orcenterline, 164 between a proximal end 166 and a closed distal end 168of the body. The body 162 is formed integrally with (1) a proximalcoupler 170 which extends axially from the proximal end 166 of the body,(2) a circular flange 172 which extends radially from the body 162, (3)an axially-elongated stem 174 formed transaxially with twoaxially-elongated diametrically-spaced slots 350 and 352, or creampassages, (4) an axially-elongated solid spacer 180, and (5) anaxially-elongated dome 182 which extends axially to the distal end 168of the body.

Also, as shown in FIGS. 9 through 14, and 16, the body 162 of each ofthe three current applicators 270, 271, and 272 is formed with the slotdelivery passage 200 to provide a path for the forced feeding of thecream 280 (FIG. 12) into the proximal end 166 of each current applicatorand toward the distal end 168 thereof. As the cream 280 is force-fedthrough the slot delivery passage 200 of each of the three currentapplicators 270, 271, and 272, respectively, the cream is force-fedthrough the entry 201, and the entry 203, of the slots 350 and 352, orcream passages, respectively, and into the respective slots. The cream280 is then fed through the slots 350 and 352, or cream passages, to anexit 350 s and an exit 352 s, respectively, of each of the three currentapplicators 270, 271, and 272, in a manner to be described below, whichis distinct in comparison to the feeding of the cream through the slots176 and 178 of each of the two prior applicators 66 and 160.

In the following description of the structure and function of the slots350 and 352 of the first, second, and third current applicators 270, 271and 272, the cream passages of the slots will be described with respectto the two-dimensional illustrations of the drawings. The thirddimensional factor of the volume of the cream passages, i.e., the slotlength “L,” (FIG. 15) is to be understood.

In the three current applicators 270, 271, and 272, as shown in FIGS. 1through 14, each slot 350 and 352 is formed with exits 350 s and 352 s,respectively. The exit 350 s is formed as a single opening with twoexit-opening sections 350 t and 350 u. The exit-opening section 350 t isaligned, in a direction of the transaxis 202, with the entry 201. Theexit-opening section 350 u is adjacent and contiguous with theexit-opening section 350 t, with at least portions thereof not intransaxial alignment with the entry 201. The exit 352 s is formed in amanner identical to the exit 350 s, and includes two exit-openingsections 352 t and 352 u. The purpose and function of the exits 350 sand 352 s will be explained below.

As further shown in FIGS. 9 through 16, in each of the first, second,and third applicators 270, 271, and 272, the slot 350, or cream passage,is formed with a single extended side wall 350 b, or extended barrierside wall, on one side only of the slot, and having the width “W.” Theextended barrier side wall 350 b is the only extended side wall in theslot 350. As particularly shown in FIG. 9, the extended barrier sidewall 350 b occupies a location comparable to the above-mentioned secondlocation within the slot 176 (FIG. 6), which is occupied by the extendedside wall 176 b of the second prior applicator 160. The location withinthe slot 350, which is comparable to the first location of the extendedside wall 176 a (FIG. 6) in the second prior applicator 160, is open, orpartially open, both as described below, and does not include anextended side wall.

Instead, as shown in FIG. 11, an abbreviated side wall 350 h is formedin the slot 350 of the first current applicator 270, and is located in aplane comparable to the plane of the extended side wall 176 a of thesecond prior applicator 160. Further, the abbreviated side wall 350 h isformed with an inboard end at the integral juncture 340 with the slotdelivery passage 200, and an outboard end at a juncture 341, where theabbreviated side wall is joined with an inboard end of an extended flatsurface 354. The abbreviated side wall 350 h and the extended flatsurface 354 are located on one a first side of the slot 350, and arespaced from (1) the extended barrier side wall 350 b, which is locatedon the a second side of the slot opposite the one first side, and (2)the transaxis plane, which is coincidental with the transaxis 202.

The width of the abbreviated side wall 350 h is less than the width “W,”and is spaced inboard from the common external surface 195. In theillustration of FIG. 11, the abbreviated side walls 350 h and 352 h areeach considerably less in width than the width “W” (FIG. 6a ) as notedabove, but could be greater than the width illustrated in FIG. 11, andstill be less than the width “W,” without departing from the spirit andscope of the invention.

As shown in FIGS. 11 and 12, and as noted above, the inboard end of theextended flat surface 354 angularly joins with the outboard end of theabbreviated side wall 350 h at the juncture 341. The abbreviated sidewall 350 h extends from the inboard end thereof, at the juncture 340,outward to the juncture 341, from which the extended flat surface 354extends angularly to a juncture 342 b with the common external surface195.

The extended flat surface 354 extends angularly outward from thejuncture 341 to the juncture 342 b with the common external surface 195at a flat-surface angle with respect to the abbreviated side wall 350 h.The extended flat surface 354 also extends away from, and in anangularly direction with respect to, the extended barrier side wall 350b, which, by virtue of the location of the slot 350, is spaced from theextended flat surface. Also, the extended flat surface 354 extendsaxially along the full axial length “L” of the slot 350.

Note that in the third current applicator 272, as shown in FIGS. 15 and16, an extended flat surface 386 does not extend the full axial lengthof the slot 350. However, the portion of the slot 350, which includesthe axially-shorter extended flat surface 386, functions in the samemanner as the slot 350 with the axially-longer extended flat surface 354of the slot 350 of the first current applicator 270. In similar fashion,the slot 352 is arranged with a flat surface 387, which extends lessthan the full length “L” of the slot. It is noted that, withoutdeparting from the spirit and scope of the invention, the slots 350 and352 of the third current applicator 272 could be formed with abbreviatedside walls 350 n and 352 h, respectively, (FIG. 11), or withoutabbreviated side walls (FIG. 13). Further, the axially-shorter extendedflat surfaces 386 and 387 (FIG. 16) could be formed with a proximal endlocated at the proximal end of the respective slots 350 and 352, and notextend to the respective distal ends of the slots, or could be formedwith proximal and distal ends which are each spaced from the proximaland distal ends of the respective slots, without departing from thespirit and scope of the invention.

As shown in FIG. 10, the flat-surface angle for the extended flatsurface 354, with respect to the extended barrier side wall 350 b isninety degrees, but could be at angles less or greater than ninetydegrees without departing from the spirit and scope of the invention. Inone representative example of a different flat-surface angle, as shownin FIG. 11, the flat-surface angle of the extended flat surface 354 isone hundred and thirty-five degrees.

As shown in FIGS. 7, 9 and 11, the first current applicator 270 isformed with a triangularly-shaped, proximal, flat transition surface 354a, which extends in a proximal direction and outward to the commonexternal surface 195 from a proximal end of the extended flat surface354, and is located adjacent a proximal transition surface 350 e, orramp. A similar triangularly-shaped, distal, flat, transition surface354 b (FIG. 7) extends in a distal direction and outward to the commonexternal surface 195 from a distal end of the extended flat surface 354,and is located adjacent the distal transition surface 350 f (FIG. 8).The proximal and distal flat transition surfaces 354 a and 354 b,respectively, form proximal and distal portions, respectively, of, andare thereby included in, the extended flat surface 354.

Referring again to FIG. 11, the first current applicator 270 is formedwith an extended flat surface 356, and an abbreviated side wall 352 hspaced from, and generally parallel with, the extended side wall 352 b,which is the only extended side wall associated with the slot 352. Asshown in FIG. 11, the abbreviated side wall 352 h is formed with aninboard end at the integral juncture 346 a with the slot deliverypassage 200, and an outboard end at a juncture 341 a with the extendedflat surface 356. The inboard end of the extended flat surface 356 islocated on one side of the slot 352, and is spaced from the extendedside wall 352 a, which is located on the opposite side of the slot.

The width of the abbreviated side wall 352 h is less than the width “W,”and is spaced inboard from the common surface 195. The extended flatsurface 356 is contiguous angularly with the abbreviated side wall 352 hat the juncture 341 a of the extended flat surface and the outboard endof the abbreviated side wall. The abbreviated side wall 352 h extendsfrom the inboard end thereof, at the juncture 340 a, outward to thejuncture 341 a, from which the extended flat surface 356 extends to ajuncture 348 a with the common external surface 195.

The extended flat surface 356 extends angularly outward from thejuncture 341 a to the juncture 348 a with the common external surface195, at a flat-surface angle with respect to the abbreviated side wall352 h. The extended flat surface 356 also extends away from, and in anangularly direction with respect to, the extended side wall 352 a,which, by virtue of the location of the slot 352, is spaced from theextended flat surface. Also, the extended flat surface 356 extendsaxially along the full axial length “L” (FIG. 15) of the slot 352.

In the illustration of FIG. 11, the abbreviated side wall 352 h isconsiderably less in width than the width “W” (FIG. 6a ), but could begreater than the width thereof illustrated in FIG. 11, and still be lessthan the width “W,” without departing from the spirit and scope of theinvention.

As noted above, the triangularly-shaped, proximal, flat transitionsurface 354 a extends from a proximal end of the extended flat surface354 and outward, in a proximal direction, to the common external surface195. A similar triangularly-shaped, distal, flat transition surface 354b (FIG. 7) extends in a distal direction and outward to the commonexternal surface 195.

In the manner described above, the extended flat surface 354, includingthe proximal and distal transition surfaces 354 a and 354 b (FIGS. 7 and8), respectively, extends the axial length “L” (FIG. 15) of the slot350, i.e., as noted above and shown in FIGS. 7 and 8, between (1) theproximal juncture 452 of the proximal transition surface 350 e and (2)the distal juncture 456 of the distal transition surface 350 f (FIG. 7),with the common external surface 195.

Similarly, as shown in FIG. 8 and as described above, the extended flatsurface 356, including the transition surface 356 a and the transitionsurface at the distal end of the slot, extends the axial length “L”(FIG. 15) of the slot 352, i.e., as noted above, between (1) theproximal juncture 452 a of the proximal transition surface 352 e withthe common external surface 195 and (2) the distal juncture 456 a of thedistal transition surface 352 f with the common external surface.

Referring to FIG. 12, the cream 280 is provided from a supply of thecream, as described above, and exits from the chamber 240, of the firstcurrent applicator 270, and enters the slot 350 through entry 201, andinto the cream passage of the slot. The cream 280 is immediatelyconfined between the extended barrier side wall 350 b and the spaced,parallel, abbreviated side wall 350 h, thereby urging the cream throughthe cream passage, in the direction of the arrow 282, and precluding anylateral movement thereof. Subsequently, the cream passes the abbreviatedside wall 350 h and a first portion of the cream continues in thedirection of the arrow 282, due to the continued barrier presence of theextended barrier side wall 350 b, and towards a first location, i.e.,the exit-opening section 350 t of the exit 350 s, and onto a firstcream-receptive surface.

The entry 201 is formed with a prescribed size and the exit 350 s islarger than the prescribed size. The exit 350 s is formed with a firstopen portion, i.e., exit-opening section 350 t, and a second openportion, i.e., exit-opening section 350 u, which is contiguous with thefirst open portion.

With the cream 280 having been moved past the abbreviated side wall 350h (FIG. 11), a second portion of the cream 280 is allowed to, and does,flow laterally, angularly of the flow direction of the first portion ofthe cream, and of the extended barrier side wall 350 b, into an enlargedchamber 353, which is an enlarged portion of the cream passage resultingfrom the formation, and flat-surface angle, of the flat surface 354. Theenlarged chamber 353, which extends the length “L” (FIG. 15) of the slot350, provides a first cream passage volume which is greater than theabove-noted prescribed volume of the cream passage of the slots 176 and178 of the second prior applicator 160. Eventually, the cream 280 passesangularly through the chamber 353, over the flat surface 354, towardsand through the exit-opening section 350 u of the exit 350 s and isapplied, or spread, angularly onto exposed surfaces of the tissue 242 ofthe patient, i.e., a second cream-receptive surface, adjacent andcontiguous with the first cream-receptive surface.

Referring further to FIG. 12, the above described structure of the slot350 and the flow path of the cream 280 therethrough applies equally tothe structure of the slot 352 and the flow path of the creamtherethrough.

Referring to FIG. 13, without departing from the spirit and scope of theinvention, in the second current applicator 271, there is no abbreviatedside wall in the location previously occupied by the abbreviated sidewall 350 h (FIG. 11) described above, and the location is open. Instead,an inboard end of an extended flat surface 354 c (also shown in dashedline in FIG. 11) is located at the juncture 340 thereof with the slotdelivery passage 200, and extends outward from the juncture toward, andto, a juncture 342 m at the common external surface 195. As noted above,the second current applicator 271 does not include the abbreviated sidewall 350 h (FIG. 11), or any side wall in place thereof.

In similar fashion, without departing from the spirit and scope of theinvention, in the second current applicator 271, and with respect to theslot 352, an inboard end of an extended flat surface 356 c is located atthe juncture 346 a thereof with the slot delivery passage 200, insteadof being located at the outboard end of an abbreviated side wall. In thesecond current applicator 271, the extended flat surface 356 c extendsoutward from the juncture 346 a toward, and to, a juncture 348 b at thecommon external surface 195. In the same above-described mannerregarding the slot 350 of the first current applicator 270, the slot 352of the second current applicator 271 will not include an abbreviatedside wall, or any side wall in place thereof.

Referring to FIG. 14, the cream 280 exits from the chamber 240, of thesecond current applicator 271, and enters the slot 350 through entry201, and into the cream passage of the slot. A first portion of thecream 280 is immediately confronted by the extended barrier side wall350 b precluding the cream from moving in a direction into the extendedbarrier wall, thereby urging the cream, through the cream passage, inthe direction of the arrow 282. The first portion of the cream continuesin the direction of the arrow 282, due to the continued presence of theextended barrier side wall 350 b, and directly towards, and through, theexit-opening section 350 t of the exit 350 s and onto pre-positioned,exposed, first portion of the surfaces of the tissue 242 of the patient.

A second portion of the cream 280, which enters the entry 201 of theslot 350 with the first portion thereof, is allowed immediately to, anddoes, flow into an enlarged chamber 353 a of the cream passage resultingfrom the formation, and selected flat-surface angle, of the flat surface354 c. The enlarged chamber 353 a, which extends the length “L” (FIG.15) of the slot 350, provides a second cream passage volume which isgreater than the above-noted prescribed volume, and is also greater thanthe above-noted first cream passage volume. Eventually, the cream 280passes through the chamber 353 a in the direction of arrows 282 a, 282 band 282 c, over the flat surface 354 c, towards and through theexit-opening section 350 u of the exit 350 s and onto pre-positioned,exposed surfaces of the tissue 242 of the patient. Note that fourtharrow 282 d reflects the additional volume of the chamber 353 a over thevolume of the chamber 353.

By forming the flat surface 354 c directly from the junction point 340,and extending the flat surface at a selected flat-surface angle, thesecond portion of the cream 280 immediately moves into the chamber 353a, which is larger than the chamber 353 (FIG. 12), and passes throughthe chamber as noted above. By virtue of the direction of movement ofthe second portion of the cream 280 as noted above, the cream approachesthe surface of the tissue 242 at an angle, resulting in the secondportion of the cream being spread onto the surface of the tissue ratherthan being fed directly onto the surface of the tissue 242 in the mannerof the first portion of the cream.

As shown in FIGS. 12 and 14, the stem 174 of the first currentapplicator 270 is located within the body opening 244 of the patient,with the illustration looking outward from within the opening. The cream280 enters the chamber 240, then, as described above, passes through theslots 350 and 352, and is applied to exposed surfaces of the tissue 242adjacent exits 350 s and 352 s, respectively, of the slots.

Thus, the structure of the second current applicator 271, as describedabove, facilitates selective placement, with selective differentamounts, of the cream 280 onto different portions of the surfaces of thetissue 242.

Referring to FIG. 15, the abbreviated flat surfaces 386 and 387 of thethird current applicator 272 could be placed at any of many locationsalong the axial length “L” (FIG. 15) of the slots 350 and 352,respectively, with a length, such as, for example, “L.sub.1” (FIG. 15)which is less than the axial length “L” without departing from thespirit and scope of the invention. For example, the respective proximalends of the abbreviated flat surfaces 386 and 387 could be located atthe proximal ends of the slots 350 and 352, respectively, and the distalends thereof located at the above-noted intermediate points (FIGS. 13and 14) of the respective slots. In another example, two or more axiallyspaced sections of abbreviated flat surfaces 386 could be located alongthe slot 350, and two or more axially spaced abbreviated flat surfaces387 could be located along the slot 352. Or, for example, the proximalends of the abbreviated flat surfaces 386 and 387 could be spaceddistally from the proximal ends of the slots 350 and 352, respectively,and the distal ends of the abbreviated flat surfaces could be spacedfrom the respective distal ends of the slots. Further, for example, theabbreviated flat surfaces 386 and 387 could be at different radialpositions along the respective slots 350 and 352, and, therefore, notradially aligned. Additionally, for example, the abbreviated flatsurfaces 386 and 387 could be formed at different flat-surface angles inthe manner illustrated in FIGS. 11 and 13.

In the above-described first, second, and third current applicators 270,271, and 272, the surfaces 354, 354 c, 356, 356 c, 386, and 387 areflat, but could be other than flat, such as, for example, at leastportions of the surfaces being formed with peaks, depressions,undulations, being concave or convex, or the like, without departingfrom the spirit and scope of the invention.

Referring to FIGS. 21 through 23, described below are various methods ofpreparing the cream-loaded syringes 40 b and 40 c, with the applicator270, to form cream delivery assemblies 535 (FIG. 21) and 535 a (FIG. 23)for use in the application of a substance, such as, for example, thecream 280, onto body surfaces of a patient, such as, for example, thetissue 242 within the body opening 244 of the patient, as shown in FIG.12.

As noted above, and as shown in FIGS. 1 and 3, the syringe 40 includesthe cartridge 42 formed with the barrel 44 having the hollow,open-ended, barrel passage 46 extending axially therethrough. Thecartridge 42 also includes, at its distal end, the axially open,internally unthreaded sleeve 64. The syringe 40, which is formed withthe frictional coupling assembly 45 (FIG. 3), differs primarily fromeach of the syringes 40 b (FIG. 21) and 40 c (FIG. 23), which are formedwith a threaded coupling assembly, such as, for example, a sleeve 64 ahaving a threaded axial passage 520 (FIG. 17), which is in axialcommunication with a barrel passage 46 a.

As shown in FIGS. 21 and 23, the syringes 40 b and 40 c, respectively,are similar in structure to the syringe 40 (FIG. 1), which is describedabove. Each of the syringes 40 b and 40 c include a cartridge 42 ahaving a barrel 44 a with the hollow, open-ended, barrel passage 46 aextending axially therethrough. The cartridge 42 a also includes, at itsdistal end, the axially open, internally threaded sleeve 64 a. Thesleeve 64 a has proximal and distal openings and a threaded axialpassage 520 (FIG. 17), which is threaded, and in axial communicationwith the barrel passage 46 a.

As shown in FIG. 17, at a transaxial juncture of the distal end of thebarrel 44 a and the proximal end of the sleeve 64 a, the diameter of aproximal opening 48 a of the sleeve is smaller than the diameter of thebarrel passage 46 a, resulting in the formation of a wall 49 at thetransaxial juncture. When the plunger 54 a is moved in a distaldirection within the barrel passage 46, the wall 49 functions as a stopto preclude travel of the plunger, in a distal direction, axially beyondthe wall. The barrel 44 a is formed with a proximal opening 50 a at aproximal end 522 of the cartridge 42 a, and the sleeve 64 a is formedwith a distal opening 523 (FIG. 17), whereby the cartridge is formedwith a continuously open axial passage from, and through, the proximalopening 50 a to, and through, the distal opening 523.

Referring further to FIGS. 21 and 23, each of the syringes 40 b and 40 cincludes a two-piece plunger 54 a formed by a plastic proximal portion526 and a compliant distal portion 528, which are assembled and securedtogether. The plastic proximal portion 526 is formed with a proximalopening 530, and with a proximal end 531.

Each of the syringes 40 a (FIG. 21) and 40 b (FIG. 23) includes a stern56 a having a flange-like thumb piece or stern depressor 532 at aproximal end thereof, and an axial coupling projection 534 at a distalend thereof, which fits into, and is retained within, the proximalopening 530 (FIG. 17) of the plastic proximal portion 526 of the plunger54 a.

As shown in FIG. 19, a syringe-like cream-supply container or dispenser536 can be used to load the cream 280 (FIG. 12) into the cartridge 42 aas described below. The dispenser 536 includes a barrel 538 formed withan axial, open ended, barrel passage 540, with a sleeve 542 extendingfrom a distal end of the barrel. An externally threaded nipple 544extends axially from the distal end of the barrel 538, and is locatedconcentrically within the sleeve 542. The nipple 544 is formed with anaxial passage 546, which is in communication with the barrel passage540, so that cream located within the barrel passage 540 can flowthrough, and out of the distal end of, the axial passage 546. Also, thedispenser 536 includes a cream pusher head 548, which is attached to adistal end of a stem 550, and which is located within the barrel passage540. A thumb piece or depressor 552 is attached to a proximal end of thestern 550, and is located outside of, and spaced from, a proximal end ofthe barrel 538. In use, a supply of the cream 280 (FIG. 12) will becontained within the barrel passage 540 of the dispenser 536, betweenthe distal end of the barrel passage 540 and a distal side of the pusherhead 548. By pressing on the depressor 552, the cream 280, within thebarrel 538, will be moved into the barrel 44 a to move or force theplunger 54 a in a proximal direction within the barrel passage 46 a.

A squeeze-tube cream-supply container or dispenser, such as the squeezetube 254 (FIG. 19), can be used as an alternative to the syringe-likedispenser 536 to load the cream 280 into the syringe 40 b or 40 c, asdescribed below. The squeeze tube 254 includes an enclosure 256 formedby a flexible wall 258 with a single-outlet nipple 260 having an axialoutlet passage 262 formed therethrough, which communicates with theenclosure. The exterior of the nipple 260 is formed with threads 264. Bysqueezing the squeeze tube 254, the cream 280, within the barrel 538,will be moved into the barrel 44 a to move or force the plunger 54 a ina proximal direction within the barrel passage 46 a.

In another cream-loading process as illustrated in FIG. 22, prior to theloading of the cream 280 into the barrel passage 46 a, and after theplunger 54 a has been placed into the barrel passage, as shown in FIG.18, a guide 566, as shown in FIGS. 22 and 23, is inserted into theproximal opening 50 a of the barrel passage until a flange 568 of theguide engages the proximal end 522 of the cartridge 42 a. The guide 566is formed with an open-ended axial passage 570, through which a stem 56b is moved and guided. The guide 566 is formed with a stop surface 572at the distal end of the guide. The stop surface 572 is located toengage the proximal end 531 of the plunger 54 a, as the plunger is movedin a proximal direction, by virtue of the force of the incoming cream280 being loaded into the barrel passage 46 a. This action limits theproximal travel of the plunger 54 a and, thereby, the volume of thecream 280 that can be loaded into the barrel passage 46 a.

Referring to FIGS. 21 and 23, it is noted that a squeeze tube 254 couldbe used in place of the syringe 40 b, with a threaded coupling assembly533, to form the cream delivery assemblies 535 and 535 a, withoutdeparting from the spirit and scope of the invention.

As noted above, several methods of loading an initial volume of thecream 280 into the cartridge 42 a. are described below, and withreference to FIGS. 17 through 23. A first of such methods includes thesteps of (1) initially providing the cartridge 42 a, having the barrel44 a, the barrel passage 46 a and the sleeve 48 a with the threadedaxial passage 520, (2) inserting the plunger 54 a into the barrelpassage 46 a from the proximal end 522 of the cartridge, (3) locatingthe distal end of the plunger at a distal end of the barrel passage 46a, (4) depositing the initial volume of the substance or cream 280 intothe axial passage 520 through the distal opening 523 at the distal endof the cartridge, and into the barrel passage; and (5) moving theplunger in a proximal direction within the barrel passage, toward theproximal end of the cartridge, by a force of the initial volume of thesubstance being deposited into the distal passage.

A second method, which includes the steps of the first method describedabove, of loading an initial volume of the cream 280 into the cartridge42 a, and further includes the steps of (1) coupling the applicator 270to the syringe 40 b at the distal opening 523 of the sleeve 48 a, (2)coupling the projection 534 of the stem 56 a to the plunger 54 a, and(3) moving the stem, and thereby the plunger, toward the distal end ofthe cartridge to urge at least some of the cream 280 from the barrelpassage, and into the applicator 270.

A third method, which includes the steps of the first method describedabove, of loading an initial volume of a substance into the cartridge 42a, further includes the step of providing the stop surface 572 (FIGS. 22and 23) within the barrel passage 46 a at a location at which theplunger 54 a is to be located when the initial volume of the cream 280has been deposited into the barrel passage. Upon depositing the cream280 into the barrel passage 46 a, the force of the initial volume of thecream moves the plunger 54 a to a location where a proximal end of theplunger is moved into engagement with the stop surface 572 to precludefurther depositing of the cream into the barrel passage.

A fourth method, which includes the steps of the first method describedabove, of loading an initial volume of a substance into the cartridge 42a, further includes the step of providing the stop surface 372 (FIGS. 27and 28) within the barrel passage 46 a at a location at which theplunger 54 a is to be located when the initial volume of the cream 280has been deposited into the barrel passage, where, upon depositing thecream into the barrel passage, the force of the initial volume of thecream moves a proximal end of the plunger into engagement with the stopsurface to preclude further depositing of the cream into the barrelpassage.

Referring to FIG. 20, a cap 560 is formed with an axially open end 561at one end thereof, with an axially closed end 563 at the opposite endthereof, and forms a removable protective cylindrical shell 562. Athreaded projection 564 extends concentrically within the shell 562 froman inner wall of the closed end 563. After the cream 280 has been loadedinto the barrel passage 46 a of the cartridge 42 a, the cap 560 ismanipulated to insert the threaded projection 564 into the threadedaxial passage 520 of the axially open sleeve 48 a of the cartridge 42 a,to retain the cream 280 within the barrel passage 46 a between the capand the plunger 54 a.

The cap 560 may also be used to retain any cream 280 remaining withinthe barrel passage 46 a between successive applications of the creamonto tissue 242 of the patient, in the event that the applicator 270 isremoved from assembly with the syringe 40 b between such successiveapplications of the cream

Each of the above-described three current applicators 270, 271, and 272is described and illustrated as being formed with two slots each;however, each of the applicators could be formed with a single slot, ormore than two slots, all without departing from the spirit and scope ofthe invention.

In general, the above-described various embodiments, as illustrated inthe drawings of this application, are not to be construed as limitingthe breadth of the present invention. Modifications, and otheralternative constructions, will be apparent which are within the spiritand scope of the invention as defined in the appended claims.

What is claimed is:
 1. A medicinal cream dispensing method comprising:providing an applicator that includes a stem defined about an axis, amedicinal cream passageway extending through the stem along at least aportion of the axis, feeding medicinal cream through an entry port incommunication with the axial passageway; moving the medicinal creamthrough the medicinal cream passageway and out from the applicator via aslot defined along a transaxis plane extending radially from the axis;an extended side wall formed in the stem, which forms a first side ofthe slot and is essentially parallel with, and spaced from, thetransaxis plane; and an angular surface formed in the stem and locatedon a second side of the slot that is opposite the first side, theangular surface is spaced and extends angularly away from the first sideand the transaxis plane.
 2. The medicinal cream dispensing method ofclaim 1 wherein the external surface is a common external surface formedon an exterior of the stem.
 3. The medicinal cream dispensing method ofclaim 1 wherein there is a second slot identical to the slot but on anopposite side of the stem.
 4. The medicinal cream dispensing method ofclaim 1 wherein there are multiple identically shaped slots dispersedalong the stem.
 5. The medicinal cream dispensing method of claim 1wherein the angular surface comprises a flat surface.
 6. The medicinalcream dispensing method of claim 1 wherein the angular surface isessentially flat.
 7. The medicinal cream dispensing method of claim 6wherein the angular surface is essentially orthogonal to the transaxisplane.
 8. The medicinal cream dispensing method of claim 1 wherein thefirst side is a leading edge and the second side is a trailing edge, theapplicator is rotated essentially in a direction from the leading edgeto the trailing edge when spun in a human body.
 9. A method ofdelivering cream through a cream passage, the method comprises the stepsof: feeding cream through an entry of a cream passage, through the creampassage, and out from a slotted exit of the cream passage, the creampassage defined along an axis of an applicator stem, the slotted exitcomprising a first elongate side that possesses a first surface that isdefined along a secondary plane that is parallel to a transaxis planethat extends through the axis, and the slotted exit comprising a secondelongated side that is essentially parallel to the first elongated sidebut possesses a second surface that is flat and angled away from thetransaxis plane; and rotating the applicator stem in a human orificeduring the feeding step.
 10. The method of claim 9 wherein the firstleading edge is spaced from the transaxis plane greater than aninfinitesimal distance from the transaxis plane.
 11. The method of claim9 wherein the second surface comprises a rounded transition from theflat to the applicator stem.
 12. The method of claim 9 wherein thesecond surface is essentially orthogonal to the transaxis plane.
 13. Themethod of claim 9 wherein there are multiple identically shaped slottedexits dispersed along the stem.
 14. The method of claim 9 furthercomprising feeding cream through a second slot on an opposite side ofthe applicator stem from the slot.
 15. The method of claim 9 wherein theentry is a port in a handle connected to the applicator stem.
 16. Themethod of claim 15 further comprising attaching a syringe to the port,the syringe containing the cream.
 17. A method for dispensing medicinalcream, the method comprising: providing an applicator stem primarilyextending along an axis; and feeding medicinal cream into an entry portthrough a passageway and out at least one elongated exit slot, theelongated exit slot comprising a first side and a second side that isparallel to the first side, the first side comprising a first flatsurface that is defined along a first plane that is parallel to atransaxis plane extending through the axis, the second elongated sidecomprising a second flat surface that is defined along a second planethat is angled from the transaxis plane.
 18. The method of claim 17rotating the applicator stem in a human orifice during the feeding step.19. The method of claim 17 wherein the second plane is essentially atright angles to the transaxis plane.
 20. The method of claim 17 whereinthe second elongated side comprises a rounded transition from the flatsurface to the applicator stem.